Senior Quality Officer (QEs and CAPAs)

PrimeVigilance; Greater London; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly working environment

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Quality Management Officer to ensure compliance with regulations regarding Quality Events and CAPAs. In this role, you will lead investigations, manage the Quality workflow, and support continuous improvement projects within a diverse and supportive work environment.

Qualifications

• Relevant experience in a Quality and/or Compliance-related role.
• Prior experience in Pharmacovigilance, Medical Information, or Medical Devices is preferred.

Responsibilities

• Lead the administration, tracking and management of Quality Events and CAPAs.
• Co-ordinate root cause investigations.
• Provide training and coaching to junior team members.

Skills

Quality Management

Root Cause Analysis

Compliance

Education

University degree in Biomedical sciences, Natural sciences or Health Sciences

Tools

Electronic Quality Management System

Job description

6 days ago Be among the first 25 applicants

Job Description

The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Job Description

The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Responsibilities

• Lead the administration, tracking and management of QEs and CAPAs at PrimeVigilance
• Co-ordinate root cause investigation meetings and support Subject Matter Experts to conduct efficient root cause analysis
• Lead QEs and CAPAs management through the workflow
• Provide support to operations and act as subject matter expert on process of managing QEs and CAPAs
• Participate and lead in business process optimization and continuous improvement projects / activities
• Exercise oversight over timely completion of action items (CAPA and Effectiveness checks) for QEs raised for US projects
• To participate in audits and inspections to act as a QE and CAPA subject matter expert (SME)
• Provide training and coaching to train the business operations and junior QE and CAPA team members with regards to Quality Management
• Support the line manager for periodic trending of deviations data across the company
• Provide peer review of QE work performed by colleagues
• Respond to audit findings and audit requests
  
  

Qualifications

• University degree in Biomedical sciences, Natural sciences or Health Sciences is required
• Relevant experience in a Quality and/or Compliance-related role
• Prior experience in Pharmacovigilance, Medical Information, or Medical Devices
• Experience of using an electronic Quality Management System desirable but not required
  
  

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We Offer

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language
  
  

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships
  
  

We look forward to welcoming your application.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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